Adults 18 to 65, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Experiencing Adverse Events (AEs) in Part 1Primary· Up to approximately 42 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 1: MK-8521 64 μg/Day
5
Part 1: MK-8521 120 μg/Day
5
Part 1: MK-8521 34 μg/Day
1
Part 1: MK-8521 72 μg/Day
4
Part 1: Liraglutide 0.6 mg/Day
2
Part 1: Liraglutide 1.2 mg/Day
7
Part 1: Liraglutide 1.8 mg/Day
2
Part 1: Placebo for MK-8521
5
Number of Participants Experiencing Adverse Events (AEs) in Part 2Primary· Up to approximately 57 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 2: MK-8521 64 μg/Day
8
Part 2: MK-8521 120 μg/Day
14
Part 2: MK-8521 180 μg/Day
6
Part 2: MK-8521 240 μg/Day
13
Part 2: MK-8521 300 μg/Day
8
Part 2: Liraglutide 0.6 mg/Day
8
Part 2: Liraglutide 1.2 mg/Day
8
Part 2: Liraglutide 1.8 mg/Day
12
Part 2: Placebo for MK-8521-T2DM
3
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
2
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
4
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 1Primary· Up to approximately 14 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 1: MK-8521 64 μg/Day
2
Part 1: MK-8521 120 μg/Day
0
Part 1: MK-8521 34 μg/Day
0
Part 1: MK-8521 72 μg/Day
0
Part 1: Liraglutide 0.6 mg/Day
1
Part 1: Liraglutide 1.2 mg/Day
0
Part 1: Liraglutide 1.8 mg/Day
0
Part 1: Placebo for MK-8521
0
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 2Primary· Up to approximately 29 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 2: MK-8521 64 μg/Day
0
Part 2: MK-8521 120 μg/Day
0
Part 2: MK-8521 180 μg/Day
0
Part 2: MK-8521 240 μg/Day
1
Part 2: MK-8521 300 μg/Day
0
Part 2: Liraglutide 0.6 mg/Day
0
Part 2: Liraglutide 1.2 mg/Day
1
Part 2: Liraglutide 1.8 mg/Day
1
Part 2: Placebo for MK-8521-T2DM
1
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
0
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
0
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1Primary· Baseline (predose Day 1) and up to 24 hours post Day 7 dose
Semi-recumbent heart rate was assessed at baseline on Day 1; Day 7 at predose, 2, 4, 6, 8, 12, 13, 14, 15, 16, 22 hours postdose; and prior to dosing on Day 8. Heart rate was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr was calculated as the area under the measurement-time curve (AUC) divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 7 minus baseline where b
Group
Value
95% CI
Part 1: MK-8521 64/120 μg/Day
7.19
3.48 – 10.89
Part 1: MK-8521 34/72 μg/Day
1.17
-2.21 – 4.55
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day
7.42
3.74 – 11.09
Part 1: Placebo for MK-8521
5.69
2.39 – 8.99
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2Primary· Baseline (predose Day 1) and up to 24 hours post Day 7 dose
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 7: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 8. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 7 minus baseline where baseline was defined as predose on Day 1.
Group
Value
95% CI
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
1.99
0.10 – 3.88
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
4.10
1.87 – 6.34
Part 2: Placebo for MK-8521-T2DM
-0.54
-3.80 – 2.73
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1Primary· Baseline (predose Day 1) and up to 24 hours post Day 14 dose
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, 13, 14, 15, 16, 22 hours postdose and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 14 minus baseline where baseline was defined as predose on Day 1.
Group
Value
95% CI
Part 1: MK-8521 64/120 μg/Day
9.67
5.97 – 13.37
Part 1: MK-8521 34/72 μg/Day
3.90
0.52 – 7.28
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day
10.32
6.65 – 14.00
Part 1: Placebo for MK-8521
9.81
6.51 – 13.12
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2Primary· Baseline (predose Day 1) and up to 24 hours post Day 14 dose
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, 16, hours postdose; and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 14 minus baseline where baseline was defined as predose on Day 1.
Group
Value
95% CI
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
5.05
2.79 – 7.30
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
5.93
3.27 – 8.60
Part 2: Placebo for MK-8521-T2DM
-0.20
-4.32 – 3.93
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 19 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2Primary· Baseline (predose Day 1) and up to 24 hours post Day 19 dose
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 19: predose, 2, 4, 6, 8, 12, 16, hours post dose; and prior to dosing on Day 20. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 19 minus baseline where baseline was defined as predose on Day 1.
Group
Value
95% CI
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
5.62
3.19 – 8.05
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
6.20
3.32 – 9.07
Part 2: Placebo for MK-8521-T2DM
-2.14
-6.66 – 2.37
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 24 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2Primary· Baseline (predose Day 1) and up to 24 hours post Day 24 dose
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 24: predose, 2, 4, 6, 8, 12, 16, hours postdose; and prior to dosing on Day 25. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 24 minus baseline where baseline was defined as predose on Day 1.
Group
Value
95% CI
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
7.30
4.43 – 10.17
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
5.95
2.50 – 9.41
Part 2: Placebo for MK-8521-T2DM
-0.99
-6.28 – 4.29
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 29 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2Primary· Baseline (predose Day 1) and up to 24 hours post Day 29 dose
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; and Day 29: predose, 2, 4, 6, 8, 12, 16 and 24 hours postdose. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 29 minus baseline where baseline was defined as predose on Day 1.
Group
Value
95% CI
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
8.30
5.31 – 11.29
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
5.84
2.26 – 9.43
Part 2: Placebo for MK-8521-T2DM
-1.31
-6.81 – 4.19
Change From Baseline in Peak Heart Rate (PHR) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2Primary· Baseline (predose Day 1) and up to 24 hours post Day 7 dose
PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 7: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 8. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 7 minus baseline where baseline was defined as predose on Day 1.
Group
Value
95% CI
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
7.94
5.76 – 10.13
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
11.91
9.30 – 14.53
Part 2: Placebo for MK-8521-T2DM
8.65
4.86 – 12.43
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1: MK-8521 64 μg/Day
Serious: 1/9 (11%)
Deaths: 0/10
Part 1: MK-8521 120 μg/Day
Serious: 0/7 (0%)
Deaths: 0/7
Part 1: MK-8521 34 μg/Day
Serious: 0/8 (0%)
Deaths: 0/8
Part 1: MK-8521 72 μg/Day
Serious: 0/8 (0%)
Deaths: 0/8
Part 1: Liraglutide 0.6 mg/Day
Serious: 0/11 (0%)
Deaths: 0/11
Part 1: Liraglutide 1.2 mg/Day
Serious: 0/11 (0%)
Deaths: 0/11
Part 1: Liraglutide 1.8 mg/Day
Serious: 0/8 (0%)
Deaths: 0/8
Part 1: Placebo for MK-8521
Serious: 0/8 (0%)
Deaths: 0/8
Part 2: MK-8521 64 μg/Day T2DM
Serious: 0/18 (0%)
Deaths: 0/18
Part 2: MK-8521 120 μg/Day T2DM
Serious: 0/18 (0%)
Deaths: 0/18
Part 2: MK-8521 180 μg/Day T2DM
Serious: 0/18 (0%)
Deaths: 0/18
Part 2: MK-8521 240 μg/Day T2DM
Serious: 1/18 (6%)
Deaths: 0/18
Part 2: MK-8521 300 μg/Day T2DM
Serious: 0/15 (0%)
Deaths: 0/15
Part 2: Liraglutide 0.6 mg/Day T2DM
Serious: 0/14 (0%)
Deaths: 0/14
Part 2: Liraglutide 1.2 mg/Day T2DM
Serious: 0/13 (0%)
Deaths: 0/13
Part 2: Liraglutide 1.8 mg/Day T2DM
Serious: 0/13 (0%)
Deaths: 0/13
Part 2: Placebo for MK-8521-T2DM
Serious: 0/6 (0%)
Deaths: 0/6
Part 2: MK-8521 64 μg/Day-Non-Diabetic Overweight/Obese
Serious: 0/8 (0%)
Deaths: 0/8
Part 2: MK-8521 120 μg/Day-Non-Diabetic Overweight/Obese
Serious: 0/8 (0%)
Deaths: 0/8
Serious adverse events (4 terms)
Reaction
System
Part 1: MK-8521 64 μg/Day
Part 1: MK-8521 120 μg/Day
Part 1: MK-8521 34 μg/Day
Part 1: MK-8521 72 μg/Day
Part 1: Liraglutide 0.6 mg…
Part 1: Liraglutide 1.2 mg…
Part 1: Liraglutide 1.8 mg…
Part 1: Placebo for MK-8521
Part 2: MK-8521 64 μg/Day …
Part 2: MK-8521 120 μg/Day…
Part 2: MK-8521 180 μg/Day…
Part 2: MK-8521 240 μg/Day…
Part 2: MK-8521 300 μg/Day…
Part 2: Liraglutide 0.6 mg…
Part 2: Liraglutide 1.2 mg…
Part 2: Liraglutide 1.8 mg…
Part 2: Placebo for MK-852…
Part 2: MK-8521 64 μg/Day-…
Part 2: MK-8521 120 μg/Day…
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Presyncope
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Other adverse events (108 terms — click to expand)
This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once daily compared to placebo and another diabetes drug in participants with Type 2 diabetes mellitus (T2DM).
This study was modified by a protocol amendment to a 2-part trial to further test the safety and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between participants with T2DM and healthy participants. An additional cohort of T2DM participants and a cohort of non-diabetic obese participants has been added.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT02492763 — A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 8 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01982630.